Kalypso
Delivering Holistic Digital Transformation for The Life Science Industry

Extended value chains and networks in the life sciences industry are becoming more global, with an increasing number of stakeholders and trading partners. Visibility of structured product, process, supply chain, risk and quality data across the value chain is a challenge due to the inherent complexity and manufacturing modalities of the industry. The various industry segments such as traditional Pharmaceuticals, Biologics, ATMP (Advanced Therapy Medicinal Products) and CDMO (Contract Development and Manufacturing Organization) add further complexity and nuance to processes that IT (Information Technology) and OT (Operational Technology) systems have to address while avoiding technical debt. It also impedes efficient tech transfer, scale-up, supply chain resilience and distributed global manufacturing.

Drug products marketed and manufactured across global jurisdictions are now requiring multiple manufacturing modalities, flexible manufacturing processes, multifaceted talent and composite organizational structures. To ultimately deliver safe, efficacious and lifesaving products to patients as quickly as possible, they also need a scalable digital strategy to improve their operational efficiencies while maintaining regulatory compliance, and ensuring data integrity.

As a digital leader in end-to-end advisory, implementation and support services, Kalypso has been perfecting digital transformation strategy and delivery for decades. Whether optimizing the product portfolio mix, accelerating speed to market, enabling digital tech transfer, improving operations performance, maximizing asset uptime and availability, optimizing supply chains, defining sustainability and energy management solutions, or managing organizational change, Kalypso assists life sciences organizations in maximizing their productivity and efficiency while decreasing time to revenue and increasing margins. Its in-depth industry knowledge, hands-on experience and established relationships with leading solution providers in the digital transformation space help it work on applicable technology solutions that solve complex business challenges for life sciences companies.

“Our experience in deploying next-generation emerging and disruptive technologies helps us focus on the digital transformation of every aspect of the value chain, from the product to the plant to the end user. This involves leveraging not one or many, but the proper digital technologies and capabilities to change the way companies discover, create, make and sell new products,” says Sachin Misra, Principal and Global Pharmaceuticals Leader at Kalypso.

Solutions that Address the Needs

Though the various industries within the life sciences space encounter slightly different issues, shared challenges affecting them today include pressure to get to market first, increased regulatory scrutiny, as well as the need to evolve automation to adaptive process control, mitigate key labor and skills shortages, and navigate the demand for flexibility in manufacturing with the emergence of personalized medicines. In addition, due to constant divestiture, merger, and acquisition activity, organizations constantly need help with a cumbersome patchwork of processes, systems, tools and disparate data. Many life sciences companies wrestle with multiple data management systems — such as electronic lab notebooks (ELN), laboratory information management systems (LIMS), product life cycle management systems (PLM), supply chain management systems (SCM), warehouse management systems (WMS), global trade management systems (GTM), enterprise resource management systems (ERP) and manufacturing execution systems (MES) — that are siloed and often don’t talk to one another leading to re-entry and transcription of data. These silos of structured, semi-structured and unstructured data impede efficient knowledge transfer and data re-use, causing data integrity issues and breaking what could otherwise be a continuous and leverageable flow of multiple digital threads of data across the value chain of the organization.

Unlocking the Power of the Digital Thread

The digital thread is a seamless flow of data that connects business processes across IT and OT to enable a datadriven record of the performance of an entire value chain – information assets, physical machines, automation and control, manufacturing processes, automation code, maintenance procedures and more.

These information sources collectively provide visibility into the past, present, and generate forward inferences and insights for assets and operations, in essence enabling the creation of digital twin techniques to plan and optimize systems and performance.

Supported with robust technology transfer, the digital thread brings greater connectivity and transparency; enables faster decision-making; and uncovers more opportunities for process improvements throughout the product life cycle.

This advanced leverage and reuse of digital data connects business processes across the organization — from product and process design to operations — all with real-time insights to accelerate innovation and increase quality and efficiency. It facilitates real-time collaboration, drastically reducing the need to email or distribute files across the organization and reconcile the inevitable version control issues that go along with that.

Fully optimized digital thread capabilities provide pinpoint control over product and process definitions, operations and quality. Such capabilities are especially useful in the critical areas of data integrity, risk mitigation and top line growth. Operational excellence is created by bringing new levels of agility and flexibility to manufacturing that increase workforce productivity and value chain resiliency. This agility with data and technology transfer translates into improved product quality and fewer instances of both planned and unplanned downtime.

“However the reality of the current state in the industry is that data assets are often siloed, not harvested, and poorly leveraged to enable a continuous digital thread. Well-defined data standards have not been translated into technology solutions to facilitate efficient internal or external knowledge collaboration and data reuse,” says Misra. “We address these pain points through our four primary service lines—consulting, data science and AI, digital and enterprise technology, and managed services.”

Consulting Services: Kalypso provides advisory services on defining the digital thread strategy, managing the portfolio of products and solutions, process and operations improvement, supply chain optimization, sustainability, IT & OT data management, and organizational design and change.

Data Science and AI: Kalypso incorporates AI and ML into existing processes or technologies for further optimization. This AI- and ML-induced optimization could be in the form of product lifecycle intelligence, natural language processing of documents into digital data, closed loop adaptive and autonomous manufacturing, model predictive control, soft sensorization, condition based monitoring, and predictive service and maintenance.

Technology: Kalypso helps companies with digital technology implementation and adoption. It provides assistance with ERP, PLM, MES, SCM, WMS, GTM, IIoT, smart connected operations (SCO), smart connected products (SCP), extended reality (AR, VR, MR), digital twin, convergence of IT & OT architectures, advanced real time analytics, and control towers.

Our key focus is on improving analytical competencies to make the shift from automation to autonomy

Managed Services: Kalypso’s managed services help clients sustain the adoption of digital solutions—whether it is application management, cloud infrastructure and hosting, or continuous improvement—until they build their own organic competencies.

“No matter where our customers are in their digital journey, we help our clients baseline their current maturity level, and help them deploy and adopt the proper enabling technologies necessary to help them move up the maturity curve. Our enterprise-level digital transformation capabilities connects their operations across the entire value chain, unlocking greater visibility and improved productivity across every operational axis,” says Misra.

Solutions that Reinvent the Entire Value Chain

Established in 2004, Kalypso was acquired by Rockwell Automation in 2020 as their digital transformation delivery organization. However, its capabilities extend beyond Rockwell’s portfolio of technologies to a broad ecosystem of digital solutions across the entire product lifecycle in the life sciences industry to maximize productivity, optimize operations, navigate a complex regulatory environment, and accelerate business growth.

The company’s comprehensive solutions to reinvent the entire product lifecycle are segmented into four critical lifecycle phases: Discover (ideation), Create (development), Make (manufacturing and supply chain operations) and Sell (including distribution, co-vigilance, and post-market surveillance activities).

Each of these lifecycle stages require different levels of digital adoption and a digital thread-centric strategy that increases connectivity between people, processes, data, systems, equipment and products.

The digital thread strategy enables proactive decisionmaking, enhanced situational awareness, and digital integrations that cross traditional boundaries. To that end, Kalypso is leveraging the application of AI and ML algorithms to clients’ existing processes to make them closed-loop and autonomous.

Kalypso helps companies mature from retrospective descriptive analytics to diagnostic, predictive, and prescriptive analytics. It has helped clients enable real-time operations and value chain visibility and optimization, with AI and ML capabilities to move beyond decision support to improved decision intelligence and adaptive control. By aggregating and contextualizing IT & OT data in near real time, Kalypso has helped organizations establish control towers that enable optimized decision intelligence at an enterprise/facility/line level and can be integrated with other control towers to enable true enterprise performance management.

“Our key focus is on improving analytical competencies to make the shift from automation to autonomy,” says Misra. This maturation of analytics can be described in four key stages:

1)Descriptive Analytics: Monitoring of key performance inhibitors. This includes retrospective and realtime monitoring of operations, WAGES, bottlenecks, alarm events, micro stoppages, etc. a. What happened?

2) Diagnostic Analytics: Incorporation of AI & ML diagnosis identifying problems, bottleneck causes and real time constraints affecting performance. a. Why did it happen?

3) Predictive Analytics: Predictions of probabilitybased potential or imminent failures or constraints leading to disruptions across facilities, equipment and lines. a. What could happen?

4) Prescriptive Analytics: AI & ML predictions on potential disruptions, along with dynamic adjustment intelligence, to plans based on real time signals and emerging constraints such as material availability, supply chain disruptions, resource availability, etc.

a. “What If ” scenario planning: Understanding trade-offs, impacts and information-based decision intelligence. b. How can I mitigate what has been predicted?: Monitoring real-time dynamic process conditions to generate forward inferences that predict what changes need to be made, down to the controls layer, to achieve the required production performance and quality and enable autonomous operations, either as human-in-the-loop decision intelligence or closedloop adaptive process control.

“Taking a holistic approach to the digital transformation process is critical in many ways, and that sentiment holds true when it comes to embracing, not just adopting, new tools. Leaders should collaborate cross functionally with members of their organization on how to best train their people on the use and application of new digital tools. Organizations should prioritize programs that focus on culture change around new tools and processes with those programs aiming to build support with leadership and staff alike,” says Misra

Misra goes on to say that the bottom line is that traditionally risk averse life sciences organizations must not fear but rather embrace digital transformation if they are to thrive and grow in this rapidly changing world. To reap the benefits of a more productive digital environment and realize the full advantages of life-changing technologies, like cloud computing, IIoT, data science and artificial intelligence, digital transformation must be planned to reverberate across the entire organization. Rather than focusing on proofs of concept and getting stuck in pilot purgatory, leaders advocating for digital transformation should organize around the practical applications of digital tools and exemplify how they solve specific business challenges. Creating digital proof points to showcase measurable business value is much more effective than high-level, hypothetical use cases, especially in life sciences.

Fostering a unique blend of industry practitioners—from strategists, technologists, and data scientists to engineering, manufacturing quality, and regulatory compliance specialists— Kalypso caters to every digital need of the client. The key capabilities it offers help companies integrate every aspect of their product value chain and unlock real time business insights to meet their business goals.